Treatment of Adipose Tissue in the ThighsNCT01823653
Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound
A study testing Liposonix System (Model 2) in people with Treatment of Adipose Tissue in the Thighs, run by Solta Medical at 4 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Adipose Tissue in the Thighs
- What is being tested?
- Liposonix System (Model 2)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18-60 years of age
- Body Mass Index of ≤30 lb/in2
- Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
- Subjects must agree not to alter their regular diet or exercise routines during the course of the study
- Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
- Subject must understand the nature of the study and sign an IRB approved Informed Consent
Who cannot join
- Subjects is pregnant
- Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
- Subject has had prior aesthetic procedures in the area to be treated
- Subjects has pacemaker, defibrillator, or other implantable electrical device
- Subject has significant circumferential asymmetry between thighs
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Jewell Plastic Surgery Center
Eugene, Oregon, 97401
Solta Medical Aesthetic Center
Hayward, California, 94545
Van Dyke Laser and Skin
Paradise Valley, Arizona, 85253
About this study
Official title: A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.
Read the detailed description
Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.
- Being tested
- Liposonix System (Model 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposonix System (Model 2)Device
Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Treated Thigh | Experimental | Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) Receives: Device: Liposonix System (Model 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement in Thigh Circumference
Clinical improvement measured by change from baseline thigh circumference after treatment
Measured: 12 weeks (minus baseline)
Secondary outcomes (5)
Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator
Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment.
*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved
Measured: 12 weeks
Patient Satisfaction Using 1-5 Likert Scale
Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below
Measured: 12 weeks
Safety Assessment
Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.
Measured: 1, 4, 8, 12 weeks
Subcutaneous Adipose Thickness
Ultrasound assisted measurement of adipose tissue thickness
Measured: 12 weeks
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement
Mean Investigator improvement at 12 weeks using the GAIS Scale.
*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment of Adipose Tissue in the ThighsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823653
- Sponsor's protocol ID
- 12-130-LP-H
- Status last verified
- Dec 2014
- First submitted
- 29 Mar 2013
- Last updated
- 31 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)
- ClinicalTrials.gov ID
- NCT01823653
- Acronym / sponsor ID
- 12-130-LP-H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Solta MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 29 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.
Detailed description
Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Thigh | Experimental | Device: Liposonix System (Model 2)Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subjects between 18-60 years of age
- Body Mass Index of ≤30 lb/in2
- Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
- Subjects must agree not to alter their regular diet or exercise routines during the course of the study
- Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
Key exclusion criteria (5 listed)
- Subjects is pregnant
- Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
- Subject has had prior aesthetic procedures in the area to be treated
- Subjects has pacemaker, defibrillator, or other implantable electrical device
- Subject has significant circumferential asymmetry between thighs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposonix System (Model 2)Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound | Device | Treated Thigh |
Primary outcome
Clinical Improvement in Thigh Circumference
Time frame: 12 weeks (minus baseline)
Clinical improvement measured by change from baseline thigh circumference after treatment
5 secondary outcomes
Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator
Time frame: 12 weeks
Patient Satisfaction Using 1-5 Likert Scale
Time frame: 12 weeks
Safety Assessment
Time frame: 1, 4, 8, 12 weeks
Subcutaneous Adipose Thickness
Time frame: 12 weeks
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposonix System (Model 2) in people with Treatment of Adipose Tissue in the Thighs, run by Solta Medical at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement in Thigh Circumference (time frame: 12 weeks (minus baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.